FDA approves bevacizumab biosimilar Mvasi

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FDA approves bevacizumab biosimilar Mvasi

Biosimilars/News | Posted 22/09/2017 0 Post your comment

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

The bevacizumab biosimilar, Mvasi (bevacizumab-awwb), is produced by biotech giant Amgen and partner Allergan. The pair submitted their application for their bevacizumab biosimilar (ABP 215) to FDA in November 2016 [1]

The product is a proposed biosimilar to Roche’s Avastin (bevacizumab), which had worldwide sales of CHF 6.7 billion (US$6.9 billion) in 2015. The patents on Avastin will expire in the US in July 2019 and in Europe in January 2022 [2].

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Mvasi has been approved for the treatment of five types of cancer, including in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC), in combination with chemotherapy for metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and in combination with chemotherapy for persistent, recurrent or metastatic carcinoma of the cervix.

FDA said that the approval was based on structural characterizations, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other safety and effectiveness data.

Mvasi has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

Amgen and Allergen also submitted an application for their bevacizumab biosimilar to the European Medicines Agency in December 2016 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-bevacizumab-biosimilar
2. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
3. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-biosimilar-application-submitted-to-EMA

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Source: Amgen, US FDA